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Heart-type Fatty Acid Binding Protein (H-FABP) Quantitative Test Cassette (Quan…
EUDAMEDClass IVD General (EU MDR)
Ref GKPD058Model 25 tests/kit
Identity
- Trade Name
- Heart-type Fatty Acid Binding Protein (H-FABP) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Device Name
- Heart-type Fatty Acid Binding Protein (H-FABP) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- 25 tests/kit EUDAMEDGKPD058 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698403779 EUDAMED
- Basic UDI-DI
- B-06977698403779 EUDAMED
- EMDN Code
- W01021302 HEART-TYPE FATTY ACID BINDING PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Heart-type Fatty Acid Binding Protein (H-FABP) Quantitative Test Cassette (Quan… by Dezhou Guoke Medical Technology Co., Ltd. — Class IVD General — IVDD…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06977698403779 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED f2f53b3e-b3b9-4e3d-9542-8d2f6b71008d 61 fields · synced Jun 18, 2026